Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Launched by CELGENE · Aug 20, 2009

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years at the time of signing the informed consent form
• • Must be able to adhere to the study visit schedule and other protocol requirements
• • Must have a documented diagnosis of B-cell CLL
• • Must be relapsed or refractory to at least 1 regimen for treatment of CLL. At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
• • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
• Exclusion Criteria:
• • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• • Active infections requiring systemic antibiotics
• • Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
• • Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
• • Prior therapy with lenalidomide
• • History of grade 4 rash due to prior thalidomide treatment
• • Planned autologous or allogeneic bone marrow transplantation
• • Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
• • Uncontrolled hyperthyroidism or hypothyroidism
• • Venous thromboembolism within 12 months
• • ≥ Grade 2 neuropathy
• • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
• • Disease transformation \[i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia\]
• • Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy